Agomelatine g.l. pharma

Package leaflet: Information for the patient

Agomelatine G.L. Pharma, 25 mg, coated tablets
Agomelatine
Please read carefully the entire leaflet before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Agomelatine G.L. Pharma is and what it is used for
2. Important information before taking Agomelatine G.L. Pharma
3. How to take Agomelatine G.L. Pharma
4. Possible side effects
5. How to store Agomelatine G.L. Pharma
6. Contents of the pack and other information

1. What Agomelatine G.L. Pharma is and what it is used for

Agomelatine G.L. Pharma contains the active substance agomelatine. It belongs to a group of medicines called antidepressants and has been prescribed to treat depression.
Agomelatine G.L. Pharma is used in adult patients.
Depression is a chronic mood disorder that affects daily life. Symptoms of depression vary among individuals but often include profound sadness, feelings of worthlessness, loss of interest in usual activities, sleep disturbances, sensations of slowing down, restlessness, and changes in body weight.
The expected effect of Agomelatine G.L. Pharma is to reduce and gradually eliminate symptoms associated with depression.

2. Important information before taking Agomelatine G.L. Pharma

When not to take Agomelatine G.L. Pharma:

• If the patient is allergic to agomelatine or to any of the other ingredients of this medicine (listed in section 6);
• If the patient's liver is not functioning properly (liver function disorders);
• If the patient is taking fluvoxamine (another medicine used to treat depression) or ciprofloxacin (an antibiotic).

Warnings and precautions
There may be several reasons why treatment with Agomelatine G.L. Pharma might not be suitable for the patient:

• If the patient is taking medicines known to affect the liver. Consult a doctor to find out which medicines are concerned.
• If the patient is obese or overweight, medical advice should be sought.
• In case of diabetes, medical advice should be sought.
• If increased liver enzyme activity has occurred in the patient since the start of treatment, the doctor will decide whether Agomelatine G.L. Pharma is appropriate for the patient.
• If the patient has bipolar affective disorder and develops symptoms of mania (periods of excessive excitement and emotional arousal), consultation with a doctor is necessary before starting or continuing treatment (see also "Possible side effects" in section 4).
• If the patient has dementia, the doctor will perform an individual assessment to determine whether Agomelatine G.L. Pharma is appropriate for the patient.

During treatment with Agomelatine G.L. Pharma:
How to proceed in order to avoid potential serious liver function disorders

• The doctor should check whether the patient's liver is functioning properly before starting treatment. In some patients, use of Agomelatine G.L. Pharma may increase liver enzyme activity in the blood. For this reason, tests should be performed with the following frequency:

Based on the results of these tests, the doctor will decide whether the patient can receive Agomelatine G.L. Pharma or continue treatment (see also "How to take Agomelatine G.L. Pharma" in section 3).
Vigilance regarding symptoms of impaired liver function is required.

• If the patient observes any of the following signs of liver dysfunction: unusually dark urine, pale stools, yellowing of the skin or eyes (jaundice), pain in the upper right part of the abdomen, unusual fatigue (especially in combination with other symptoms listed above), immediate medical advice should be sought. The doctor may decide to discontinue treatment with Agomelatine G.L. Pharma.

The efficacy of Agomelatine G.L. Pharma has not been documented in patients aged 75 years and older. For this reason, Agomelatine G.L. Pharma should not be used in such patients.
Suicidal thoughts and worsening of depression
If the patient suffers from depression, they may sometimes experience thoughts of self-harm or suicide. These may worsen at the beginning of treatment with an antidepressant, as all such medications take time to become effective—usually about two weeks, sometimes longer.
The occurrence of such thoughts may be more likely if:

• the patient has previously had suicidal or self-harming thoughts;
• the patient is a young adult. Clinical trial data show an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressant medications. If the patient ever experiences thoughts of suicide or self-harm, they should immediately contact their doctor or go to a hospital.

It may be helpful to inform a relative or close friend that the patient has depression and ask them to read this leaflet. The patient may ask them to inform the patient if they notice worsening depression or are concerned about changes in the patient’s behaviour.
Children and adolescents
Agomelatine G.L. Pharma is not intended for use in children and adolescents under 18 years of age.
Agomelatine G.L. Pharma and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Agomelatine G.L. Pharma should not be taken simultaneously with certain medicines (see also "When not to take Agomelatine G.L. Pharma" in section 2): fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic) may alter the blood concentration of agomelatine.
Remember to inform the doctor if the patient is taking any of the following medicines: propranolol (a beta-blocker used to treat high blood pressure), enoxacin (an antibiotic), or if the patient smokes more than 15 cigarettes per day.
Taking Agomelatine G.L. Pharma with alcohol
Drinking alcohol during treatment with Agomelatine G.L. Pharma is not recommended.
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
Breast-feeding
The patient should inform the doctor if she is breastfeeding or intends to breastfeed, as breastfeeding must be discontinued during treatment with Agomelatine G.L. Pharma.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
The patient may experience dizziness or drowsiness, which could affect the ability to drive or operate machinery. The patient should ensure their reactions are adequate before driving or operating machinery.
Agomelatine G.L. Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to take Agomelatine G.L. Pharma

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.

The recommended dose of Agomelatine G.L. Pharma is one tablet (25 mg) taken before bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets taken together before bedtime.

In most patients with depression, Agomelatine G.L. Pharma begins to work on depressive symptoms within two weeks of starting treatment. Your doctor may recommend continuing treatment with Agomelatine G.L. Pharma even after you start feeling better, to prevent depression from returning.

Depression should be treated for a sufficient length of time, at least 6 months, to ensure that symptoms have resolved.

Do not stop taking Agomelatine G.L. Pharma without consulting your doctor, even if you feel better.

Agomelatine G.L. Pharma is for oral use. Swallow the tablet with water.

Agomelatine G.L. Pharma may be taken with or without food.

How to switch from an SSRI/SNRI antidepressant to Agomelatine G.L. Pharma?

If your doctor changes your antidepressant treatment from an SSRI (Selective Serotonin Reuptake Inhibitors) or SNRI (Serotonin Norepinephrine Reuptake Inhibitors) to Agomelatine G.L. Pharma, they will advise you on how to discontinue the previous medicine when starting Agomelatine G.L. Pharma.

For several weeks, you may experience withdrawal symptoms related to stopping the previous medicine, even if the medicine is tapered gradually by reducing the dose. Withdrawal symptoms include: dizziness, tingling sensations, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor. These symptoms are usually mild or moderate and resolve spontaneously within a few days.

If Agomelatine G.L. Pharma is started while tapering the dose of the previous medicine, do not confuse possible withdrawal symptoms with lack of early effect from Agomelatine G.L. Pharma.

When starting treatment with Agomelatine G.L. Pharma, you should discuss with your doctor the best way to discontinue the previous antidepressant medicine.

Liver function monitoring (see also section 2)

Before starting treatment and periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks, and 24 weeks, your doctor will recommend blood tests to check whether your liver is functioning properly.

If your doctor decides to increase the dose to 50 mg, tests should also be performed at the beginning of the higher dose, followed by periodic checks after 3 weeks, 6 weeks, 12 weeks, and 24 weeks. Further tests may be recommended if your doctor considers them necessary.

Do not take Agomelatine G.L. Pharma if your liver is not functioning properly.

If you have kidney function disorders, your doctor will perform an individual assessment of your condition and decide whether treatment with Agomelatine G.L. Pharma is safe for you.

Taking more than the recommended dose of Agomelatine G.L. Pharma

If you have taken more than the recommended dose of Agomelatine G.L. Pharma, or if a child has accidentally swallowed the medicine, contact your doctor immediately.

Experience with overdose of Agomelatine G.L. Pharma is limited, but reported symptoms include upper abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or general malaise.

Missing a dose of Agomelatine G.L. Pharma

Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.

Stopping treatment with Agomelatine G.L. Pharma

Before stopping treatment with Agomelatine G.L. Pharma, discuss this with your doctor.

If you feel that the effect of Agomelatine G.L. Pharma is too strong or too weak, consult your doctor or pharmacist.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
Most adverse reactions are mild or moderate in severity. Adverse reactions usually occur within the first two weeks of treatment and are usually transient.

The following adverse reactions may occur:

• Very common (may affect more than 1 in 10 people): headache.
• Common (may affect up to 1 in 10 people): dizziness, somnolence, sleep disturbances (insomnia), nausea, diarrhoea, constipation, abdominal pain, back pain, fatigue, anxiety, unusual dreams, increased liver enzyme activity in blood, vomiting, weight gain.
• Uncommon (may affect up to 1 in 100 people): migraine, sensation of pins and needles in fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder characterised by an uncontrollable urge to move the legs), tinnitus, excessive sweating, rash, itching, urticaria, agitation, irritability, restlessness, aggressive behaviour, nightmares, mania or hypomania (see also “Warnings and precautions” in section 2), suicidal thoughts or suicidal behaviour, confusion, weight loss.
• Rare (may affect up to 1 in 1000 people): severe skin reactions (rash with erythema), facial swelling and angioedema (swelling of the face, lips, tongue and/or throat, which may cause breathing or swallowing difficulties), hepatitis, yellowing of the skin or whites of the eyes (jaundice), liver failure*, hallucinations, inability to remain still (due to physical and mental restlessness), inability to completely empty the bladder. * Several cases have been reported which resulted in liver transplantation or death.

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Agomelatine G.L. Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Agomelatine G.L. Pharma contains

• The active substance is agomelatine. Each coated tablet contains agomelatine with citric acid, equivalent to 25 mg of agomelatine.
• Other ingredients are:
  Tablet core: microcrystalline cellulose silicon dioxide (microcrystalline cellulose and colloidal anhydrous silicon dioxide), mannitol, povidone 30, colloidal anhydrous silicon dioxide, crospovidone (type A), sodium stearyl fumarate, magnesium stearate, stearic acid 50.
  Coating: hypromellose 2910/5, macrogol 6000, titanium dioxide (E 171), talc, iron oxide yellow (E 172).

What Agomelatine G.L. Pharma looks like and contents of the pack
Agomelatine G.L. Pharma is yellow, elongated, biconvex coated tablets, 9.00 mm in length and 4.5 mm in width.
Agomelatine G.L. Pharma is available in blister packs.
The pack contains 28 tablets.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria

Manufacturer
G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria
MEDIS International a.s., vyrobni zavod Bolatice
Prumyslova 961/16
74723 Bolatice
Czech Republic

For further information and information on the medicinal product names in other EEA countries, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75
00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]